In recent years, it has been required to comply with the standards (guidelines) on the process control and quality control prescribed in the GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice) or comply with the standards on electronic documents prescribed in 21 CFR PART 11 (U.S. regulations on electronic records and electronic signatures) when performing an analysis on a sample, particularly in research institutes which handle food, pharmaceuticals, medical tools or similar products. To comply with those standards, it is necessary to provide, in addition to the analyzing device control systems or analysis data processing systems, an information management system which checks, for example, that those system are appropriately administered, and that the control data, analysis data and other relevant data used in those systems are appropriately managed.
One of the targets managed by such an information management system is the control command data and control parameter data for controlling analyzing devices. For example, in an analysis performed on a sample using an analyzing device, the data which represent control commands and control parameters for operating the analyzing device are previously saved in the form of a file (“analysis execution file”). When the analysis is performed, the analysis operator specifies this analysis execution file to make the analyzing device perform the analysis under predetermined conditions with preset parameters. By using only an analysis execution file which has been duly created and checked as well as proved to be valid. (authenticated), the analysis is correctly carried out. The same applies to the analysis of the data obtained through a measurement (analysis data).
Therefore, when such an analysis execution file or other relevant data that have been duly authenticated are changed, it is necessary to correctly recognize and manage that change. Conventional information management systems are provided with the functions of monitoring such a change in the data.